The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / Etanercept Biosimilars Promising in Clinical Studies

Etanercept Biosimilars Promising in Clinical Studies

December 2, 2015 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

GENERIC_Drugs_500x270In a 52-week clinical study, an investigational biosimilar for etanercept, SB4, showed lasting efficacy (including radiographic progression), immunogenicity and safety.1 This trial was a randomized, double-blind study in adults with moderate to severe rheumatoid arthritis (RA), despite methotrexate treatment.

You Might Also Like
  • Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting
  • Tofacitinib Released from FDA REMS Requirement; Plus Biosimilars for Etanercept & Adalimumab Show Promise
  • Biosimilar Drug Updates Reported from EULAR
Also By This Author
  • Tanezumab Promising for OA Pain; Plus, Filgotinib Investigated for Psoriatic Arthritis

Five hundred and ninety-six patients were randomized to receive either SB4 (n=299) or Enbrel (etanercept; ETN) (n=297). The ACR20 response rate was 81% in patients who received SB4 vs. 82% in those who received ETN. Additionally, the ACR50 and ACR70 response rates were slightly higher for SB4 compared with ETN.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The safety profiles were also comparable. One treatment-emergent adverse event occurred in 59% of SB4-treated patients vs. 60% of ETN-treated patients; and injection-site reactions occurred in 4% vs. 18% of SB4- and ETN-treated patients, respectively (P<0.001). At Week 52, at least one anti-drug antibody result occurred in 1% and 13% of SB4- and ETN-treated patients, respectively (P<0.001). The serious infection, tuberculosis and malignancy rates were all comparable.

CHS-0214 is another investigational ETN biosimilar. The treatment met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study evaluating its efficacy and safety in patients with moderate to severe chronic plaque psoriasis.2 The efficacy endpoints were based on a 12-week assessment of Psoriasis Activity Severity Index (PASI) scores. The primary endpoints were the mean percent change in PASI from baseline and the proportion of patients achieving 75% improvement in PASI from baseline. These results met the pre-specified limits for demonstrating an equivalence to ETN. No clinically meaningful differences were noted in the safety profiles of the two products evaluated.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. Encovsky J, Sylwestrzak A, Leszczyñski P, et al. A phase 3, randomized, double-blind clinical study comparing SB4, an etanercept biosimilar, with etanercept reference product (Enbrel) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (52-week results). Arthritis Rheumatol. 2015 Sep; 67(9, suppl 10).
  2. Coherus BioSciences Inc. New release: Coherus and Baxalta announce CHS-0214 (investigational etanercept biosimilar) met primary efficacy endpoints in phase 3 psoriasis clinical study (RaPsODY). 2015 Nov 10.

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Biosimilars, etanercept, plaque psoriasis, Rheumatoid Arthritis (RA)

You Might Also Like:
  • Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting
  • Tofacitinib Released from FDA REMS Requirement; Plus Biosimilars for Etanercept & Adalimumab Show Promise
  • Biosimilar Drug Updates Reported from EULAR
  • Guselkumab Studied to Treat RA, Plaque Psoriasis

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)